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Comparing the accuracy of a novel wrist-watch blood pressure monitor against standard clinical blood pressure monitors in detecting how high blood pressure affects heart structure

Relationship between blood pressure profiles measured by a wrist-type blood pressure monitor (HeartGuide) and left ventricular mass index

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN69980195
Enrollment
50
Registered
2021-03-26
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease, hypertension (elevated blood pressure) Circulatory System Hypertensive diseases

Interventions

This is an observational study in people with elevated blood pressure (BP). The study will compare relationships between out-of-office blood pressure measurements, i.e. BP measurements made by study p

Sponsors

University College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Men or women aged 35 years or older 2. Seated clinic systolic BP =130 mmHg or previously diagnosed with hypertension and currently taking prescription medication to lower BP 3. Wrist circumference 16-19 cm (i.e. suitable for HeartGuide watch BP monitor) 4. Willing and able to provide informed consent

Exclusion criteria

Exclusion criteria: 1. People who are unable or unwilling to provide informed consent 2. Women who are pregnant 3. Participants with a wrist circumference >19 cm (unsuitable for the HeartGuide wrist monitor) 4. Participants with an upper arm circumference >42.0 cm (unreliable cuff-based BP measurement) 5. Participants unwilling or unable to undergo a cardiac MRI scan 6. Participants unwilling or unable to undertake a minimum of 3 consecutive weekdays of wrist blood pressure monitoring (using the HeartGuide watch BP monitor) 7. Participants unwilling or unable to undertake a continuous 24-hour period of ambulatory blood pressure monitoring 8. Participants with sustained atrial fibrillation or other significant arrhythmia (makes BP measurement unreliable) 9. People currently enrolled in another on-going clinical trial or study

Design outcomes

Primary

MeasureTime frame
1. “Out of office” systolic BP, measured using the HeartGuide watch BP monitor at Baseline – Visit 1 2. Left ventricular mass index (LVMI) measured by cMRI at Baseline – Visit 3

Secondary

MeasureTime frame
1. Mean BP indices measured by the HeartGuide watch BP monitor at baseline – Visit 1 2. Mean BP indices measured by 24-hour ambulatory BP monitoring (ABPM) at baseline – Visit 2 3. Mean BP indices measured by seated clinic BP at baseline – Visit 1 4. Heart wall thickness measured as left ventricular mass index (LVMI) or unindexed left ventricular (LV) mass by cardiac MRI (cMRI) at baseline – Visit 3 5. Arterial stiffness measured using the Cardio-Ankle Vascular Index (CAVI) at baseline – Visit 1 6. ECG voltage criteria for LV mass measured at baseline – Visit 1 7. cMRI parameters including LVMI/unindexed LV mass, cardiac volumes and indices of vascular structure/function at baseline – Visit 3

Countries

England, United Kingdom

Contacts

Public ContactDonna Moskal-Fitzpatrick
donna.moskal@ucl.ac.uk+44 (0)207 679 9425; +44 (0)758 250 9320

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026